Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke

NCT ID: NCT06060470

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2028-10-01

Brief Summary

Neurological impairment such as stroke is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke is tedious, resource-intensive, and costly, often requiring transportation of patients to specialized facilities. Based on recent evidence suggesting significant benefits of repetitive, task-orientated training, investigators propose to evaluate the feasibility of an alternative therapies such as exergaming-based therapy to improve overall physical function of community-dwelling individuals with neurological impairments, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain data on compliance and efficacy of a randomized controlled trial. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals.

Detailed Description

While conventional balance training facilitates balance control and gait functions, the exercises involved in the training are labor-intensive, highly repetitious leading to monotonicity and decreased motivation levels. Therefore, many health care researchers are involved in identifying various methods to reduce the risk of falls addressing the barriers in conventional training methods while having the potential to translate it at home. Pilot studies with dance-based exergaming resulted in improving balance control and cognition post-stroke. Based on this preliminary finding, this current study aimed to identify:

1. The evaluate using the randomized controlled trial the efficacy of dance-based exergaming on physical function compared to conventional standard of care (fall prevention and balance training) among people with chronic stroke This pilot studies used Wii-fit Nintendo/ Microsoft Kinect, an off the shelf, commercially available and a cost-effective device that provides similar benefits of exergaming. Community-dwelling people with chronic stroke involved in the study underwent 6 weeks of exergaming or conventional balance training in a tapering manner in a laboratory setting. Participants were assessed for motor and cognitive performance in the laboratory during volitional and reactive balance control while performing a secondary cognitive task. The performance outcome determined the effect on physical function.

Conditions

Chronic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Virtual reality based dance group

Virtual-reality based dance training - Participants received Virtual-reality based dance training for 10 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) "Just Dance 3". The first six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song. The first 6 weeks are conducted in the laboratory. The next four weeks are conducted in the participants home via telerehabilitation. The four week sessions consisted of 3 sessions/week.

Group Type: EXPERIMENTAL

Virtual reality based dance group

Intervention Type: BEHAVIORAL

Participants will receive therapy using the "Just Dance" using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists.

Control

Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors.

Group Type: ACTIVE_COMPARATOR

Active Comparator: Control

Intervention Type: BEHAVIORAL

Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors.

Interventions

Virtual reality based dance group

Participants will receive therapy using the "Just Dance" using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists.

Intervention Type: BEHAVIORAL

Active Comparator: Control

Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors.

Intervention Type: BEHAVIORAL

Other Intervention Names

Active Balance Cardio (ABC) care; Control

Eligibility Criteria

Inclusion Criteria

• 45 to 90 years of age.
• Able to follow instructions provided in English.
• History of neurological impairment (Stroke) for at least 6 months prior to evaluation (self-report, confirmed by participant's physician).
• Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
• Cognitive skills to actively participate (score of < 26 on Montreal cognitive assessment indicates cognitive impairment).
• Stroke - a) Upper extremity limb function (score of at least 25 on the Fugyl Myer Upper extremity test and Muscle performance grade on deltoid, pec major and and triceps of > or = 2/5).

Exclusion Criteria

• Cognitive or communicative impairment indicated by a score of > 26 on Montreal cognitive assessment and a score of <25 on Mini Mental State Exam Score;
• aphasia <71% on Mississippi Aphasia Screening Test
• >15 on Geriatric Depression Scale.
• unhealed pressure sores,
• active or untreated infection,
• thromboembolic disease,
• severe contractures,
• active heterotrophic ossification in the lower extremities,
• lower limb fractures,
• known history of peripheral nerve injury in the lower legs,
• history of cardiovascular or pulmonary complications, or with pacemakers and history of metabolic (endocrine, hepatic) or renal dysfunction, uncontrolled seizures (Self-report).
• History of any acute and significant cardiopulmonary, musculoskeletal or systemic diagnosis in the past 6 months or history of a recent major surgery (<6months) or hospitalization (<3months) and on any sedative drugs.
• Partcipants unavailable for 12 weeks of participation,
• Current participation in other treatment (i.e.- Botox) or other research studies during the phase of the study.
• Pregnancy.
• Uncontrolled pain >3/10 on VAS.
• Complains of shortness of breath
• Uncontrolled hypertension (systolic blood pressure (SBP) > 165 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during resting).
• Resting hear rate (HR) > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age) [3].
• Oxygen saturation (measured by pulse oximeter) during resting < 95%.
• T score of < -2 on the Bone density, measured through via the heel ultrasound machine.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Savitha Subramaniam

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Savitha Subramaniam

Role: PRINCIPAL_INVESTIGATOR

uic

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Central Contacts

Savitha Subramaniam

Role: CONTACT

ssubra26@uic.edu

17082910471

savitha subramaniam

Role: CONTACT

savitharaj@gmail.com

17082910471

Facility Contacts

Savitha Subramaniam, PhD

Role: primary

ssubra26@uic.edu

708-291-0471

Other Identifiers

STUDY2023-1087

Identifier Type: -

Identifier Source: org_study_id